Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Product description
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
Lot numbers, UPCs & expiration codes
Lot # 37-894320, Exp 04/29/2023; 37-894324, Exp 04/29/2023; 37-897297, Exp 05/12/2023; 37-898509, Exp 05/15/2023
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0674-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2023
- FDA report date
- May 31, 2023
- Quantity
- 208 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0674-2023, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 92253
- Address
- 6580 Snowdrift Rd Ste 100
- Code information
- Lot # 37-894320, Exp 04/29/2023; 37-894324, Exp 04/29/2023; 37-897297, Exp 05/12/2023; 37-898509, Exp 05/15/2023
- Postal code
- 18106-9331
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0674-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 208 bags
- Termination date
- Jun 22, 2025
- Reason for recall
- Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 28, 2023
- Initial firm notification
- Center classification date
- May 19, 2023